Obesity treatment and device

ABSTRACT

A method and apparatus are disclosed for treating obesity includes an artificial fistula created between gastrointestinal organs such as between the stomach and the colon. The method includes selecting an implant comprising a passageway having an internal lumen with an inlet end and an outlet end. The passageway is positioned passing through a first wall of first gastrointestinal organ (for example, passing through the wall of the stomach) and a second wall of a second gastrointestinal organ (for example, passing through the wall of the large intestine) with the inlet end disposed within an interior of the first gastrointestinal organ and with the outlet disposed within an interior of the second gastrointestinal organ.

I. CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/141,869, filed May 31, 2005, now U.S. Pat. No. 7,803,195 whichapplication is incorporated herein by reference, which claims priorityto U.S. Provisional Patent Application Ser. Nos. 60/576,826; 60/589,429;60/603,705 and 60/612,088 with respective filing dates of Jun. 3, 2004,Jul. 20, 2004, Aug. 23, 2004 and Sep. 22, 2004.

II. BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention pertains to a method and apparatus for treating obesity.More particularly, this invention pertains to an apparatus and methodfor treating obesity with an implant in the gastrointestinal system toalter at least one of satiety, absorption and digestion.

2. Description of Prior Art

A. Obesity as a World-Wide Health Dilemma

Morbid obesity and its concurrent health risks (including diabetes,heart disease and other ailments) are of near-epidemic proportions inindustrialized societies. A wide variety of treatments have beenproposed and attempted to treat morbid obesity with a wide variety ofefficacy and associated morbidity. These treatments include techniquesto reduce stomach volume, alter gastric and intestinal motility, andalter the absorption of nutrients in the small intestine.

Clearly, obesity is a complex disease having physiologic, social andpsychological components which are not fully understood. The complexnature and the enormous societal implication of obesity require a widevariety of treatment options be available to permit a physician toselect a most appropriate option for a particular patient.

Even if all treatments were proven effective, no one treatment can meetthe clinical needs presented by a diverse population. For example,current bariatric surgeries, such as the Roux-en-Y procedure as will bedescribed, is not considered suitable for only so-called mildly obesepatients (e.g., those with a Body Mass Index less than 35). Also, forextremely obese patients, operative risks may make this procedureundesirable.

Less invasive procedures (such as gastric banding, as will be described)have reduced surgical risk. Unfortunately, they suffer from reducedefficacy (and they are not without risks). Further, efficacy may beculturally biased. Namely, gastric banding studies show reduced efficacyin North American patients compared to European patients.

B. Selected Obesity Treatments

a. Surgical Options (Non-Device)

i. Gastric Volume Reduction

Surgical approaches to gastric volume reduction include minimallyinvasive surgery, open surgery and endoscopic approaches to gastricvolume reduction. Many such procedures have been tried and some havebeen abandoned due to lack of efficacy or unacceptable morbidity andmortality.

The gastric volume reduction procedures include vertical and horizontalgastroplasty in which sutures, staples or other fixation devices areused to join opposing surfaces of the stomach to create a reduced volumepouch and thereby reduce caloric intake.

Gastric stapling, as used herein, refers to staples or stitches in thestomach to reduce stomach size. These include horizontal gastroplastyand vertical gastroplasty.

Surgical gastric volume reduction is focused on reducing the fundus toinduce satiety. Recent studies suggest antral volume more directlyinfluences satiety. Strum, et al., “Energy Intake and Appetite areRelated to Antral Area in Healthy Young and Older Subjects”, AmericanJournal of Clinical Nutrition, 80 (3), pp. 656-657 (2004).

Less invasive techniques for restricting the volume of the stomach alsoinclude a gastric partition in which the stomach wall is endoscopicallycinched together to form a reduced size pouch. The cinching is performedusing commercially available products such as the Bard EndoCinch™ andthe Wilson-Cook Sew-Right™ cinching equipment. Such surgical equipmentis generally described in U.S. Pat. No. 5,088,979 to Filipi et al.issued Feb. 18, 1992; U.S. Pat. No. 6,302,917 to Dua et al. issued Oct.16, 2001 or PCT International Publication No. WO 01/89393 published Nov.29, 2001.

It has been recognized that gastric volume reduction does not addressall mechanisms associated with obesity. For example, patients withgastric volume reduction can defeat the effectiveness of the gastricvolume reduction by modifying eating habits. For instance, a patient maygraze continuously on small volume, high caloric food or may replacesolid foods with high caloric liquid foods.

ii. Surgeries with Malabsorptive Components

To address deficiencies associated with gastric volume reduction,treatments have been suggested and developed for reducing the amount ofnutrient absorption in the small intestine (particularly in the upperand middle portions of the small intestine—the duodenum and jejunum,respectively).

In the duodenum, ducts from the pancreas and gall bladder discharge intothe small intestine through small protrusions referred to as papilla.Commonly, pancreatic exocrine secretions (“PES”) flow from the pancreasin a pancreatic duct. Similarly, bile from the gall bladder flowsthrough a bile duct. These ducts merge to form a common duct withdischarges through a papilla into the duodenum. In some patients, thebile duct and pancreatic duct do not merge. They separately dischargeinto the duodenum at separate papilla which, usually, are in closeproximity to one another.

Techniques to reduce nutrient absorption (commonly referred to asmalabsorption treatments) include drug therapies for reducing lipidsabsorption. Such drug therapies have uncomfortable side effects, whichcan discourage a patient from complying with the drug therapy.

Other malabsorption treatments include surgical techniques for reroutingthe intestinal system to bypass an extended portion of the smallintestine. These include a so-called jejunoileal bypass. Not commonlyused due to unacceptable mortality rates, a jejunoileal bypass wouldresult in effective weight loss. Other techniques include the gastricbypass (or Roux-en Y) and duodenal switch. In both of these procedures,a large segment (e.g., in excess of 100 cm) of the small intestine(including the duodenum) are bypassed so that food content is reroutedfrom a small pouch formed in the upper portion of the stomach to thejejunum. As a result, the absorptive length of the small intestine issignificantly shortened thereby reducing the amount of nutrients whichare absorbed into the body and which support or lead to weight gain.These procedures combine the benefits of gastric volume reduction withmalabsorption. Unfortunately, such surgical procedures are extremelyinvasive.

b. Implantable Mechanical Devices

i. Gastric Volume and Delayed Gastric Emptying

1. Gastric Banding

Less invasive techniques are suggested for placing a band (referred toas LAP bands) around an upper portion of the stomach to act as a belt toreduce the size of the stomach and create a small passageway (a stoma)from a small upper pouch to the remainder of the stomach. An example ofa LAP band is shown in U.S. Pat. No. 5,266,429 to Kuzmak dated Jul. 13,1993. LAP bands and other gastric bandings are disclosed in Schauer, etal, “Surgical Management of Gastroesophageal Reflux Disease in ObesePatients”, Seminars in Laparoscopic Surgery, Volume 8, Number 4, pages256-264 (2001). Such LAP bands wrap around a portion of the fundus tocreate a greatly reduced volume portion of a fundus above the LAP band.Such bands create an upper chamber above the band to create a sensationof satiation after consuming only a small volume of food. See also, U.S.Pat. No. 5,549,621 to Bessler et al., dated Aug. 27, 1996; U.S. Pat. No.5,226,429 to Kuzmak dated Jul. 13, 1993 and U.S. Pat. No. 4,592,339 toKuzmak et al. dated Jun. 3 1986.

2. Intra-Gastric Balloons

Other techniques for reducing gastric volume size include placement ofobstructions within the stomach. These include intra-gastric balloonswhich are filled with saline to reduce the effective volume of thestomach. Examples of such balloons or other intragastric devices includethose shown in U.S. patent application publication No. US 2001/0037127to de Hoyos Garza published Nov. 1, 2001 (describing a percutaneousintragastric balloon to treat obesity); U.S. patent applicationpublication No. 2002/0055757 to Tone, et al., published May 9, 2002;U.S. patent application publication No. 2004/0093091 to Gannoe, et al.,published May 13, 2004 (describing an anchored intragastric balloon);U.S. patent application publication No. 2004/004357 to Gannoe, et al.,published Mar. 4, 2004 (describing various techniques for retaining anintragastric balloon in a location in the stomach) and U.S. patentapplication publication No. 2003/0158601 Silverman published Aug. 21,2003.

3. Pyloric Narrowing

U.S. patent application publication No. 2004/0019388 to Starkebaumpublished Jan. 29, 2004 describes treating obesity by injecting bulkingagents into the pylorus. U.S. patent application publication No.2004/0037865 to Miller published Feb. 26, 2004 describes varioustechniques to narrow the pylorus to slow gastric emptying to treatobesity. For example, the '865 application describes injecting bulkingor stiffening agents into the pylorus. The application also describesablation or scarring to narrow the pylorus as well as suturing thepylorus to narrow it.

U.S. patent application publication No. 2004/0089313 to Utley, et al.,May 13, 2004 describes treating the pylorus to slow or meter gastricemptying. The '313 application describes treating tissue at the pyloruswith an agent to tighten tissue or with a bulking agent. The applicationalso describes treating the pylorus with an agent to interrupt afferentnerve impulses that trigger transient sphincter relaxation. Theapplication also describes applying ablative energy to the pylorus,using magnets to tighten the pylorus or placing bands around thepylorus.

U.S. patent application publication No. US 2002/0188354 to Peghinipublished Dec. 12, 2002 teaches a device to treat obesity by obstructingthe gastric outlet at the pylorus. The '354 application describes adevice for obstructing the pylorus to create a sensation of satiety. Theobstruction is a sandglass shaped device having bulges placed onopposite sides of the pylorus (one in the stomach, the other in thesmall bowel) with a narrow bridge spanning the pylorus. The device isformed of plastic and endoscopically delivered and fluid filled.

U.S. patent applications Publication Nos. US 2005/0033331 and US2005/0055039 describe pylorus obstruction devices and methods.

4. Other

There fore-going description of prior art patents is not intended to beexhaustive. In the patent literature, there are many other suggestionsfor treating obesity. For example, U.S. patent application PublicationNo. 2003/0158601 to Silverman, et al., published Aug. 21, 2003 describesinjections of implants in the stomach wall near the pylorus to inhibitgastric emptying. U.S. patent application Publication No. 2004/0172142to Stack, et al., published Sep. 2, 2004 describes covered stent-likestructures in the antrum and duodenum and bridging the pylorus.

ii. Devices to Promote Malabsorption

Less invasive techniques for restricting absorption have been suggested.They include bariatric sleeve devices such as those disclosed in USPatent Application Publication Nos. 2004/0092892 to Kagan, et al.,published May 13, 2004 and 2004/0107004 to Levine, et al., publishedJun. 3, 2004. In these techniques, sleeves are passed through theduodenum so that chyme (the contents of the intestines) are passedthrough the sleeve and do not interact with the absorptive walls of theintestine. The sleeves may be perforated to permit some of the chymematerial to pass through the walls of the small intestine and beabsorbed as nutrients. The sleeve of the '004 application includes astent in the pylorus. The stent keeps the pylorus permanently open toinduce a so-called “dumping syndrome”.

The bypass of the duodenum results in reduced absorption of desirednutrients (e.g., calcium) as well as undesirable nutrients (such asfat). Particularly, the loss of calcium absorption is significant sincesuch loss can lead to osteoporosis.

A suggestion has been made to divert the digestive enzymes from thepancreas past the duodenum. Such a suggestion is shown in theafore-mentioned US Patent Application Publication No. 2004/0092892. Inan embodiment of the '892 application, a tube is placed through thepapilla and into the ducts of the gall bladder and the pancreas. Adistal end of the tube is positioned significantly distal to the papillasuch that pancreatic exocrine secretion and bile are divertedsignificantly distally to the papilla resulting in a reduction ofabsorption.

While pancreatic diversion is scientifically interesting, cannulation ofthe pancreatic duct carries significant risks. Such cannulation of thepancreatic duct has been performed in endoscopic retrogradecholangiopancreatography (ERCP). Patients under-going ERCP and/orrelated procedures are known to have a higher likelihood of developingpancreatitis. It has been reported that the incidence of post-ERCPpancreatitis can be as high as 28%. Fazel et al., “ProphylacticPancreatic Duct Stenting: A Panacea”, Gastroenterology, Vol. 124, No. 4,pp. 1274-1275 (2003). Pancreatitis is a very serious disease which canbe fatal.

c. Electrical Neural Stimulation

There have been a number of suggestions to treat obesity by applyingelectrical stimulation. For example, two patents assigned to Cyberonics,Inc. describe purported obesity treatments involving stimulation signalsapplied to the vagus nerve to up-regulate vagal activity to near aso-called “retching threshold”. These are U.S. Pat. Nos. 6,587,719 and6,609,025).

U.S. Pat. No. 6,615,084 to Cigaina dated Sep. 2, 2003 (assigned toTransneuronix) delivers direct smooth muscle stimulation to the stomachthrough a laparoscopically placed lead connected to an implantable pulsegenerator. Similarly, U.S. Pat. No. 5,423,872 to Cigaina dated Jun. 13,1995 describes placing electrodes on the abdominal wall.

A number of patents and patent applications are assigned to IntrapaceInc pertaining to an endoscopically delivered direct stimulation devicefor the treatment of obesity. Examples of these are U.S. Pat. No.6,535,764; US 2003/0167025; US 2003/016024; WO 02/087657; and WO02/089655.

Also, proposed stimulation therapies include technologies to providedirect gastric stimulation to create a ‘banding’ effect on the stomachformed by contracted muscle. U.S. Pat. No. 6,571,127 to Ben-Haim et al.,dated May 27, 2003 describes applying a field to a GI tract to increasethe force of contraction. U.S. Pat. No. 6,600,953 to Flesher et al.,dated Jul. 29, 2003 describes a set of electrodes on the stomach whichcause a contraction to decrease a cross-section of the stomach.

d. Electrical Neural Block

Recent novel treatments include vagal modulation to block neuralimpulses on the vagus nerve to down-regulate pancreatic exocrinesecretion production as well as alter gastric accommodation. Suchtreatments are shown in U.S. Patent Application Publication No.2004/0172086 A1 to Knudson, et al.

III. SUMMARY OF THE INVENTION

A method and apparatus are disclosed for treating obesity. In oneembodiment, an artificial fistula is created between gastrointestinalorgans such as between the stomach and the colon. The method includesselecting an implant comprising a passageway having an internal lumenwith an inlet end and an outlet end. The passageway is positionedpassing through a first wall of first gastrointestinal organ (forexample, passing through the wall of the stomach) and a second wall of asecond gastrointestinal organ (for example, passing through the wall ofthe large intestine) with the inlet end disposed within an interior ofthe first gastrointestinal organ and with the outlet disposed within aninterior of the second gastrointestinal organ. An additional embodiment,which may be used in combination or separately, includes a passagewaydefining a lumen with an inlet and an outlet. The passageway is sized tobe passed through a pylorus of a patient with a lumen inlet residing ina stomach of a patient and with a lumen outlet residing in a duodenum ofthe patient. The lumen is dimensioned to restrict a flow of contents toan amount less than a flow of stomach contents through an untreatedpylorus.

IV. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a patient's gastro-intestinalsystem illustrating various anatomic components;

FIG. 2 depicts one exemplary embodiment of a device according to thepresent invention in one location within the gastrointestinal system ofa patient and with the device in FIG. 2 showing an optionalmalabsorption sleeve;

FIG. 3 depicts an esophagogastroduodenoscope advanced from the stomachinto the duodenal segment of the small intestine during a deploymentprocedure;

FIG. 4 depicts a guidewire extending from theesophagogastroduodenoscope;

FIG. 5 depicts a device according to the present invention beingadvanced over the guidewire of FIG. 4;

FIG. 6 depicts the device of FIG. 5 in position bridging the pylorus ofthe patient;

FIG. 7 depicts the device of FIG. 6 during expansion of expandablechambers;

FIG. 8 depicts the device of FIG. 7 after further expansion of theexpandable chambers;

FIG. 9 depicts the device of FIG. 8 after removal of an expansioncatheter;

FIG. 10 is a longitudinal cross-sectional view of the device of FIG. 2without showing an optional sleeve;

FIG. 11 is a view taken along line 11-11 of FIG. 10;

FIG. 12 is a longitudinal cross-sectional view of an alternativeembodiment of the device of the present invention;

FIG. 13 is view taken along line 13-13 of FIG. 12;

FIG. 14 is a longitudinal cross-sectional view of a further alternativeembodiment of the device of the present invention;

FIG. 15 is a longitudinal cross-sectional view similar to that of FIG.10 (without showing an inflation lumen) and showing, in exploded format,optional plug inserts;

FIG. 16 is a longitudinal cross-sectional view similar to that of FIG.10 (without showing an inflation lumen) and showing an optional sleeve;

FIG. 17 is a view of a still further embodiment of the present inventionin situ with a proximal expansion chamber substantially filling anantrum;

FIG. 18 is a view similar to that of FIG. 17 and showing a modifiedversion of the device of FIG. 17;

FIG. 19 is a schematic diagram of an alternative embodiment of thepresent invention having a valve to control flow of contents through thedevice;

FIG. 20 is a longitudinal cross-sectional view of a device with apassageway which can collapse in response to pyloric forces;

FIG. 21 is the view of FIG. 20 where the passageway is reinforced toresist collapse in response to pyloric forces;

FIG. 21A illustrates an alternative embodiment with a double walledchamber for drug delivery;

FIG. 22 is a schematic view of an apparatus and method for bypassing alength of absorptive tissue of the duodenum;

FIG. 23 is a longitudinal cross-sectional view of an inlet end of apassageway with an optional screen;

FIG. 24 depicts one exemplary embodiment of a treatment system includinga primary gastric flow control device deployed in the pyloric sphincterand a secondary gastric flow control device deployed between the stomachand the colon;

FIG. 25 is a view similar to FIG. 25 showing a deployed primary gastricflow control device a showing a first step in deploying a secondarygastric flow control device;

FIG. 26 is a view similar to FIG. 26 and showing a further step indeploying a secondary gastric flow control device;

FIG. 27 is a view similar to FIG. 27 and showing a still further step indeploying a secondary gastric flow control device; and

FIG. 28 depicts an alternative secondary gastric flow control devicethat may be used in connection with the present invention.

V. DESCRIPTION OF A PREFERRED EMBODIMENT

In the following detailed description of some exemplary embodiments ofthe invention, reference is made to the accompanying figures of thedrawing which form a part hereof, and in which are shown, by way ofillustration, specific embodiments in which the invention may bepracticed. It is to be understood that other embodiments may be utilizedand structural changes may be made without departing from the scope ofthe present invention.

A. Relevant Anatomy and Physiology

With initial reference to FIG. 1, relevant aspects of a patient'sgastrointestinal system are illustrated. These include the stomach Swhich is provided with food from the esophagus E. A lower esophagealsphincter LES is shown positioned between the esophagus E and thestomach S. The lower esophageal sphincter normally provides control ofreflux of stomach contents into the esophagus E.

On a proximal or lower end of the stomach S, the stomach discharges intothe superior duodenum D which is an upper portion of the smallintestine. The superior duodenum D and the stomach S are separated by apyloric valve or sphincter PL. Normally closed, the pyloric valve PVopens to permit gastric emptying from the stomach into the duodenum D.

A pancreatic duct PD extends from the pancreas P and discharges into thesuperior duodenum D. Bile also passes through a separate bile duct BD.In most patients, the bile duct BD merges with the pancreatic duct PD toform a common duct CD which enters into the duodenum D at a commonpapilla CP. The common papilla CP is also referred to as the “ampulla ofvater” or the “papilla of vater”.

The upper portion of the stomach (i.e., the fundus F) receives food fromthe esophagus E. The lower portion of the stomach (the antrum A) is aregion of greatest grinding and digestion as well as the source ofcompulsive forces (antropyloric waves) for urging digested food (chyme)through the pylorus PL and into the most proximal end of the duodenum D(the duodenal bulb DB).

Having described the relevant anatomy, a description of the presentinvention will now be provided. First to be described will be a deviceto treat obesity by narrowing the pylorus to delay gastric emptying.Next, a device to create an artificial gastric-colonic fistula will bedescribed.

As will become apparent, either of the two following concepts can beseparately used to treat obesity. However, last to be described will bea description of a treatment method incorporating a coordinated usage ofboth concepts.

B. Pyloric Narrowing and Delayed Gastric Emptying

a. General Description Structure of the Pyloric Device

FIG. 2 depicts a first embodiment of a device 10 according to thepresent invention. In FIG. 2, the device 10 is shown deployed within thegastrointestinal system of a patient. The device 10 includes apassageway 20, a first expandable chamber 30, and a second expandablechamber 40. An optional sleeve 50 is located distal of the secondexpandable chamber 40.

The device 10 is deployed with the passageway 20 spanning the pylorusPV. The first expandable chamber 30 of the device 10 is located withinthe gastric antrum A. The second expandable chamber 40 of the device 10is located in a proximal end of the duodenum D (the “duodenal bulb”)distal of the pyloric sphincter PV. As shown in FIG. 2, the device 10may include an optional expansion port 12.

As will be described, port 12 is used to expand one or more expandablechambers (i.e., chambers 30, 40) of the device 10. The optional sleeve50 may preferably extend into the duodenum with or without extensioninto the jejunum. The sleeve 50 provides a partial or full bypass of alength of absorptive tissue of the duodenum such that absorption ofnutrients passing therethrough may be reduced or prevented.

The foregoing general description of the device 10 is intended tofacilitate an understanding of the deployment of the device 10 as willnow be described. It is intended an understanding of the deployment andpositioning of the device 10 will facilitate an understanding of afurther specific discussion of the construction of the device (includingmaterial selection and sizing of components with respect to anatomicfeatures).

b. Deployment of the Pyloric Device

The device 10 has a distinct advantage over many other prior arttreatments in that it can be delivered endoscopically without the needfor general anesthetic. Deployment of the device 10 may be through anysuitable method. By way of non-limiting example, such a deployment isillustrated in FIGS. 3-9. These Figures show insertion of the device 10over a flexible guidewire that is placed in the small intestine duringan initial esophagogastroduodenoscopy (EGD).

FIG. 3 depicts positioning of a esophagogastroduodenoscope 100 withinthe duodenum D. The scope 100 can be placed orally, as in conventional,to pass through the esophagus E and into the stomach S and be advancedinto the duodenum D.

A guidewire 102 (shown in FIG. 4) is disposed within an interior lumenof the scope 100. As shown in FIG. 3, the esophagogastroduodenoscope 100is retracted proximally while leaving the guidewire 102 in positionwithin the duodenum D.

A device 10 such as that depicted in FIG. 1 is passed over the guidewire102 by passing the wire 102 through a lumen 21 of the hollow passageway20 (FIG. 5). A catheter 14 is also passed over the guidewire 102proximal to the device 10. The catheter 14 acts as a push tube to beurged against the device 10 and push it distally as shown in FIG. 5.

As shown in FIG. 5, the device 10 is shown in a collapsed state withchambers 30, 40 deflated. An inflation catheter 16 is connected toexpansion port 12 to provide an expansion fluid to later inflate thechambers 30, 40 as will be described.

Also as shown in FIG. 5, the esophagogastroduodenoscope 100 ispreferably reinserted into the stomach alongside the device 10 of thepresent invention to allow for direct visualization of the deployment ofthe device 10. It will be appreciated that for small sized devices 10,the device 10 may be inserted through a working channel in theesophagogastroduodenoscope 100.

The device 10 is advanced distally over the guidewire 102 by advancingthe push catheter 14 to push the device 10. Such advancement continuesuntil the distal expansion chamber 40 of the device 10 is located withinthe duodenum D just distal to the pylorus PV as shown in FIG. 6. Theexpansion catheter 16 is advanced with the device 10.

FIG. 6 illustrates a preferred deployment position in which the distalexpandable chamber 40 is located within the duodenal bulb past thepyloric sphincter PV. The proximal expandable chamber 30 is locatedwithin the gastric antrum GA. If the device 10 includes an optionalsleeve 50 as depicted in FIG. 1, it may be advantageous to advance theentire device 10 to a location farther into the duodenum D followed bymovement of the device 10 proximally during deployment to reduce thelikelihood that the sleeve 50 is folded back upon itself within theduodenum D.

After the device 10 is properly located within the gastrointestinaltract (as seen in, e.g., FIG. 6), the expandable chambers 30 and 40 canbe expanded. Expansion of both chambers 30 and 40 is depicted in FIGS. 7and 8.

If expansion is achieved by an attached expansion catheter 16 (asillustrated), the catheter 16 may preferably be separated from thedevice 10 after expansion and removed. FIG. 9 depicts the device 10 withchambers 30, 40 fully expanded and with expansion catheter 16 removed.

Withdrawal of the push catheter 14 is also illustrated in FIG. 9. Insome instances, it may be advantageous to use theesophagogastroduodenoscope 100 to apply pressure in the distal directionon the device 10 to assist in removal of an expansion catheter 16 from,e.g., expansion port 12 on the device 10. Such distal pressure preventsundesired proximal displacement of the device 10 from the desireddeployed position illustrated in the Figures.

Applying distal pressure with the scope 100 as described is particularlydesirable where the catheter 16 is fit onto the port 12 in a slidingengagement as illustrated. Alternatively, an expansion catheter 16 maybe attached to expansion port 12 using a clip or other structure thatcan be opened to allow removal of the expansion catheter 16. Othernon-sliding contacts and removals can include severing of the connectionbetween the catheter 16 and port 12.

After the catheters 14 and 16 are removed, the guidewire 102 is distallywithdrawn. Removal of the guidewire 102 leaves the expanded device 10 inposition as seen in FIG. 2.

c. Removal of the Pyloric Device

One of the many benefits of the treatment of the present invention isthat it is reversible by removing the device 10. Removal of a device 10may be effected by a variety of methods.

Removal will typically involve deflation or another action that causesthe expanded chambers 30 and 40 to have a reduced volume. If theexpandable chambers 30 and 40 are expanded using a fluid, puncturing thechambers 30 and 40 may be used to deflate them.

If the chambers are in fluid communication with each other, puncturingone of the chambers may be sufficient to deflate both chambers. If thechambers are independently expandable as described herein, each of thechambers may need to be deflated separately.

It may be desirable to deflate the distal chamber 40 first to preventdistal migration of the device that could occur if the proximal chamber30 was deflated first.

If puncturing is to be used to deflate the chambers, the puncturing maybe accomplished using, e.g., biopsy forceps, needle, a snare with orwithout a short delivery of cauterizing energy, endoscopic scissors,etc. It may also be advantageous to use a snare in combination with aneedle or other puncturing device such that the device of the presentinvention can be grasped or secured for removal after deflation.Grasping the device with a snare or other device before deflation mayhelp prevent distal migration during the removal process.

The devices of the present invention may preferably be adapted fordelivery into the gastrointestinal system endoscopically, although otherplacement techniques and methods may also be possible. A variety ofdifferent delivery methods and structures may be described in, e.g.,U.S. Pat. Nos. 4,315,509 (Smit); 4,501,264 (Rockey); and 5,306,300(Berry); as well as U.S. Patent Publication No. US 2003/0040804 A1(Stack et al.).

d. Additional Description of Device Structure

FIGS. 10 and 11 depicts the device of FIG. 2 outside of thegastrointestinal system of the patient. In FIG. 10, the optional sleeve50 is not shown.

The passageway 20 is a hollow, flexible tube having an internal lumen 21with an inlet 22 and an exit 24 spaced apart along a longitudinal axisX-X. As deployed within the gastrointestinal system of a patient asdepicted in FIG. 2, it is preferred that the inlet 22 be located withinthe stomach (preferably within the gastric antrum) and that the outlet24 be located distal of the pyloric sphincter PL, preferably within theduodenal bulb BD. Preferably, the passageway 20 is bendable transverseto the axis X-X to permit ease of deployment as well as ease of passingthe device 10 in the event it becomes displaced.

The device 10 includes the first expandable chamber 30 located proximatethe inlet 22 of the passageway 20. The expandable chamber 30 maypreferably be generally toroidal in shape with an axial opening 31through which the passageway 20 is positioned. By “generally toroidal”it is meant that the expandable chamber 30 may take the shape of atoroid in general. The shape may, however, not necessarily be ageometrically perfect toroid. Rather, the toroid may not exhibitsymmetry in any plane.

The device 10 also includes a second expandable chamber 40 locatedproximate the outlet 24 of the passageway 20. The second expandablechamber 40 may also preferably be generally toroidal in shape asdiscussed above in connection with the first expandable chamber 30. Theexpandable chamber 40 has an axial opening 41 through which thepassageway 20 is passed. Central positioning of the outlet 24 in thechamber 40 maximizes the displacement of the outlet 24 from the walls ofthe duodenum thereby reducing a risk of bile reflux into the stomach.

The expansion chambers 30, 40 are bonded to the passageway 20 in anysuitable means. For example, they can be bonded to the passageway in thesame manner inflatable balloons are bonded to balloon-tipped catheters.The chambers 30, 40 define internal bounded volumes 33, 43 for receivingan inflating medium as will be described.

The tubular wall of the passageway 20 contains an inflation lumen 24 influid flow connection with volumes 33, 43 via ports 34, 44. Theinflation port 12 is connected to the inflation lumen 12 by acheck-valve 13 (schematically illustrated).

The first and second expandable chambers 30 and 40 be separated alongthe longitudinal axis X-X of the passageway 20 by a spacing S₁. Thespacing S₁ is selected to locate the proximal expandable chamber 30within the gastric antrum opposing the pylorus PL while the distalexpandable chamber 40 is located in the duodenal bulb B opposing thepylorus PL. A representative spacing S₁ is about 5 to 10 mm but mayinclude inflation so chambers 30, 40 are snug against opposing tissuewith a force less than a force that would otherwise result in pressurenecrosis. With this spacing S₁, the chambers provide a squeeze againstthe pylorus PL to prevent migration of the device 10.

The diameter D₁ of the expansion chambers 30, 40 is also selected toprevent migration of the device 10 after placement. Preferably, thisdiameter D₁ is greater than the maximum opening of the pylorus PL. Byway of non-limiting example, the pylorus of an adult may opensufficiently large to pass an object of 2.5-3 cm. Therefore, the chamberdiameter D₁ is preferably greater than 4 cm and more preferably greaterthan 5 cm. The surface of the proximal chamber 30 opposing the pylorus Pmay be reinforced to stiffen the chamber 30 to further resist migration.

Also, the chamber diameter D₁ is selected to avoid undue pressureagainst opposing tissue. Excessive pressure against tissue can lead topressure necrosis, ulceration or other injury. The duodenum D has athinner wall than the antrum A and is more susceptible to pressureinjury. During inflation of the chambers 30, 40, pressure can bemonitored to avoid undue pressure.

The internal diameter D₂ of the lumen 21 is selected to be narrower thana maximum opening of the pylorus PL. In a presently preferredembodiment, the size of the lumen 21 is selected to have a maximumdiameter of about 8 mm. As a consequence, a smaller amount of digestedfood can be passed into the duodenum for any given amount of time. Inaddition to limiting the amount of chyme available for absorption, theinvention results in delayed gastric emptying (increased gastricretention) with an increased sense of satiety. Preferably, the wall ofthe passageway 20 is reinforced so that the lumen 21 remains patent inresponse to opposing forces of the pylorus which would otherwise urgethe lumen 21 to close.

e. Alternative Structures

i. Separately Inflatable Chambers

FIGS. 12-13 illustrate an alternative embodiment device 10′. In theembodiment of FIGS. 12-13, elements in common with device 10 aresimilarly numbered with the addition of an apostrophe to distinguish theembodiments.

In the device 10′, the chambers 30′, 40′ are separately inflatable.Instead of having a common inflation lumen 24 of device 10, device 10′has two inflation lumens 24 a′, 24 b′ separately connected to chambers40′, 30′ through ports 44′, 34′. Each lumen 24 a′, 24 b′ has a separateinflation port 12 a′, 12 b′ and check valve 13 a′, 13 b′.

With this embodiment, greater pressure can be applied to the proximalchamber 30′ to increase antral pressure and create an enhanced sensationof satiety. The increased pressure of proximal chamber 30′ is nottransmitted to the distal chamber 40′ and, hence, not transmitted to theduodenal wall.

ii. Adjustable Passageway Lumen

In the preferred embodiment, the lumen 21 remains patent at all timesand at a constant diameter D₁ (FIG. 10). If desired (and as illustratedin FIG. 21), the passageway 20 can include reinforcing rings 23 ofstainless steel or other reinforcing structure to resist collapse of thelumen 21 in response to pyloric forces. Alternatively, the passageway 20can be selected of materials for the lumen to be collapsible to close inresponse to pyloric forces as illustrated in FIG. 20. In such case, thelumen diameter is not constant but varies between closed and the maximumdiameter D₁ representing a maximum lumen opening.

FIGS. 14 and 15 illustrate alternative embodiment devices 10″ and 10″.In the embodiment of these figures, elements in common with device 10are similarly numbered with the addition of double and tripleapostrophes to distinguish the embodiments. For ease of illustration theinflation lumens (such as lumens 24, 24 a′, 24 b′ of embodiments 10,10′) are not shown. With such plugs, a very restrictive plug can by usedto promote rapid weight loss. Then, a less restrictive plug could beused to maintain a desired weight.

The device 10″ of FIG. 14 has a balloon lining 23″ along the length ofthe passageway 20″ and within the lumen 21″. The balloon 23″ has aninflation port 12″ and check valve 13″. Inflation of the balloon 23″narrows the diameter of the lumen 21″.

Other options are available for narrowing the passageway lumen. FIG. 15illustrates an embodiment were plugs 25 a, 25 b, 25 c can be placed inthe lumen 21′″. The plugs 25 b, 25 c have a lumens 21 b, 21 c ofprogressively smaller diameter than the passageway lumen 21′″. Differentplugs of different lumen sizes can be available to permit a physician totitrate a treatment for an individual patient. Indeed, a solid plug 25 acould be used on a temporary basis if desired. Each plug 25 a, 25 b, 25c has a capped end 27 a, 27 b, 27 c shaped to be received on end 22′″ tohold the plug 25 a, 25 b, 25 c in the lumen 21′′.

iii. Enlarged Antral Chambers

FIG. 17 illustrates an embodiment of a device 210 having a proximalexpansion chamber 230, distal expansion chamber 240 and passageway 220and lumen 221 similar to that of device 10. However, the proximalexpansion chamber 230 is sized to occupy a substantial volume of theantrum A. For example, the chamber can have a maximum diameter of about20 and length L of about 20 cm.

When inflated, the chamber 230 fills the antrum. In addition tonarrowing the pylorus as in the embodiment of device 10, the device 210(by reason of the large chamber 230) isolates stomach content from thegrinding and propelling action of the antrum A thereby further enhancingthe mal-digestive nature of the invention. Filling chamber 230 with acompressible fluid further isolates food in the stomach S from antralgrinding since the compression fluid absorbs the forces. The enlargedchamber 230 also reduces the stomach volume and has a potential forcreating a bigger satiety effect.

In FIG. 17, the lumen 221 is of uniform cross-section throughout. FIG.18 illustrates an alternative embodiment. In the embodiment of FIGS.12-13, elements in common with device 210 are similarly numbered withthe addition of an apostrophe to distinguish the embodiments. In FIG.18, the lumen 221′ has an enlarged or trumpet shaped entrance end 222′of the lumen 221′. If desired, end 222′ can be provided with apurse-string suture (not shown) or other mechanism to collapse end 222′for delivery or removal.

iv. Washed Inlet

FIG. 23 illustrates a passageway inlet 22 with an optional ring 25spaced from the inlet by support posts 27. In the event food might coverand block the ring, chyme flow between the posts 27 acts to wash thering and clear it of debris.

v. Valved Device

FIG. 19 is a schematic diagram of another exemplary embodiment of thepresent invention. In FIG. 19, the device 410 includes a passageway 420and proximal and distal expandable chamber 430 and 440 as described withreference to device 10.

FIG. 19 illustrates an additional optional feature as a valve 480 tocontrol the movement of nutrients through the passageway 420. The valve480 may have many different constructions. In some embodiments, valve480 may be a one-way valve to reduce the likelihood that materials willmove from the outlet 424 to the inlet 422 of the passageway 220, e.g.,from the duodenal bulb to the stomach.

In other embodiments, the valve 480 may act as a flow restrictor byproviding a reduced opening through which nutrients pass when movingthrough the passageway.

The size of the orifice provided by the valve 480 may be selected beforethe device is deployed within a patient. When employed as a static flowrestrictor, the valve 480 will preferably not completely obstruct thepassageway 420.

In still other embodiments, the valve 480 may be adjustable afterdeployment within a patient using, e.g., a control mechanism 482. Thevalve 480 and control mechanism 282 may be capable of completely closingthe valve 480. Such closure prevents movement of nutrients through thepassageway 420. Alternatively, the valve 480 and control mechanism 482may be limited to adjusting the amount of flow restriction in thepassageway 420 without the ability to completely close the passageway420.

It may be preferred that the control mechanism 482 be controlled by acontroller 484 located outside of the patient. Communication between thecontroller 484 and the control mechanism 482 may be accomplished byusing any suitable remote control technique, e.g., telemetry, opticalenergy, acoustic energy, etc.

The valve 480 and control mechanism 482 (if provided) may be of anysuitable construction and use any suitable actuation principles, e.g.,hydraulic, pneumatic, mechanical (e.g., a shutter valve, bandrestriction around a passageway), magnetic, etc. Examples of somepotentially suitable valve constructions may be described in, e.g., U.S.Pat. Nos. 6,067,991; 6,210,347 B1; 6,453,907 B1; 6,454,699 B1; 6,460,543B1; 6,461,293 B1; 6,471,635 B1; and 6,475,136 B1 (all to Forsell). Atleast some of the documents identified above also describe somepotentially suitable controllers 284 and control techniques for use inconnection with implanted valves and valve control mechanisms.

In some embodiments, the valve 480 may be controlled based on pressure.For example, the valve 480 may be controlled based on a separatepressure sensor implanted at a suitable location within the patient.Pressure control may be used as a primary control technique for opening,closing and/or adjusting the orifice in the valve 480 and/or as a safetyfeature wherein the valve 480 opens in response to pressures that aredeemed excessive. Potentially suitable pressure control systems andtechniques may also be described in at least some of the documentsidentified herein.

Also, although described separately, devices according to the presentinvention may include valves that are both one-way valves and that areconfigured to restrict flow, i.e., the same valve may function toprevent backflow through the passageway and restrict flow in the desiredin direction. Alternatively, devices according to the present inventionmay include more than one valve, e.g., a one-way valve to preventbackflow and one or more additional valves to control the rate of flowthrough the passageway in the desired direction.

vi. Combination with Pancreatic Secretion Bypass

Still another embodiment of the present invention is schematicallydepicted in FIG. 22. The depicted device 310 includes a first expandablechamber 330 and a second expandable chamber 340 which can be aspreviously described. The first expandable chamber 330 is preferablylocated on the antral side of the pyloric sphincter (i.e., proximal thepyloric sphincter) and the second expandable chamber 340 is preferablylocated on the opposite side of the pyloric sphincter PL.

The depicted device further includes a passageway 320 as described withreference to device 10 but longer for reasons that will become apparent.The passageway has inlet 322 that is preferably located within thestomach S (preferably within the gastric antrum A) and an exit 324.Unlike the other embodiments described herein, the passageway 320extends to a third expandable chamber 360 such that the exit 324 of thepassageway 320 is located distal of the chamber 360. As a result, foodentering the passageway 320 through the inlet 322 preferably does notexit the passageway 320 until it passes the third expandable chamber360. When deployed, it is preferred that the third expandable chamber360 be located distal to the common papilla CP and be sized such thatwhen expanded, the chamber 360 contacts the wall of the small intestinesuch that fluid cannot pass between the chamber 360 and the interior ofthe small intestine.

The common papilla CP is the exit point for the common duct CD whichcarries secretions from the pancreas (enzymes and proteases) and bileacids from the liver via the gall bladder. The expandable chamber 360preferably contains a tube 370 to collect the majority of bile andpancreatic secretions and channel these secretions further down thesmall intestine (e.g., to the jejunum) to delay or prevent the bile andpancreatic secretions from interacting with food. It may be preferred,e.g., that the third expandable chamber 360 be located approximately 5-6centimeters distal to the second expandable chamber 340 which shouldplace the third expandable chamber 360 below the common papilla CP.

The tube 370 that is separate from the passageway 320 through which foodpasses. While the proximal surface of the chamber 360 is shown asconvex, it may be concave or take some other shape such that bile andpancreatic exocrine secretions are directed into the inlet 372 of thebile channel 370. The bile channel 370 preferably transports secretionsfarther down the small intestine where they pass out of the tube 370through the exit 374. Isolating the secretions in this manner delays orprevents them from interacting with food, which may thereby reducefat/calorie absorption. The tube 370 may preferably have a length of,e.g., 150-200 centimeters.

The devices of the present invention may preferably be adapted fordelivery into the gastrointestinal system endoscopically, although otherplacement techniques and methods may also be possible. A variety ofdifferent delivery methods and structures may be described in, e.g.,U.S. Pat. Nos. 4,315,509 (Smit); 4,501,264 (Rockey); and 5,306,300(Berry); as well as U.S. Patent Publication No. US 2003/0040804 A1(Stack et al.).

vii. Material Selection Options

In a preferred embodiment, the lumen 21 is described as beingcontinuously patent. However, as an alternative embodiment, the materialof the passageway 20 can be selected to that the lumen 21 may collapsein a radial direction in response to pyloric forces. In such anembodiment, the passageway 20 acts to limit the maximum opening.

The devices of the present invention may be manufactured of a variety ofmaterials. Preferably, the materials used in the devices will becompatible with long-term exposure to ingested food, gastrointestinalfluids (e.g., low pH stomach fluids and high pH intestinal fluids),mechanical stresses associated with the gastrointestinal system, etc.

Examples of some suitable materials for the passageway, expandablechambers, sleeves, etc. may include, but are not limited to, polymericmaterials (e.g., silicone elastomers, polyethylenes, polyetherpolyurethanes (e.g., TEGADERM), polytetrafluoroethylenes (PTFE), andother materials. One or both of the chambers (e.g., 30, 40) or otherballoons (e.g., balloon 23″) may be made of distensible ornon-distensible material (such options being known for balloons ofballoon tipped catheters).

If metallic materials such as wires, struts, meshes, etc. areincorporated into the devices of the present invention, they mayinclude, e.g., shape memory metals (such as nickel-titanium alloys),stainless steel, etc. In some instances, the devices of the presentinvention may include shape memory polymers for one or more differentcomponents such as the expandable chambers, etc.

viii. Expansion Options

The preferred embodiment describes fluid to chambers 30, 40 to causechamber expansion. The expansion port 12 may take a variety of formsdependent on the nature of the expandable chambers and the devices usedto expand the chambers. For example, the expandable chambers may beexpanded using fluids (liquids and/or gases) such as, e.g., saline,carbon dioxide, air, etc. In some instances, the fluids used may beselected for their viscosity characteristics.

If desired, a dye (such as methylene blue or another biologically inertbut detectable material) can be added to the expansion fluid. In theevent an expansion chamber is ruptured, the present of the dye in stoolprovides a visual indication of rupture.

It may be advantageous to incorporate features into the device to allowfor visualization of the location of the device (e.g., radiopaquemarkers, etc.) when the device is deployed within the body of a patient.Visualization may be helpful if migration of the device is suspectedafter deployment. In addition, it may be helpful to manufacture thedevices of the present invention of materials that have a pliability andflexibility to pass through the gastrointestinal tract if migrationoccurs.

A dense fluid can be used to expand the chambers 30, 40. A dense fluidadds weight to the device 10 which increases the sensation of satiety.

Other than the check valves, other options may be used to inflate thechambers. For example, the passageway material can be a self-sealingpolymer. Inflation fluid can be admitted to the inflation lumen throughneedle injection.

Although the expandable chambers 30, 40 are described herein asexpanding due to the delivery of fluids, expansion of the expandablechambers of some devices according to the present invention may beassisted by wires or other structural members made of stainless steel,shape memory metals, shape memory polymers, etc.

ix. Malabsorption Sleeve

FIGS. 2 and 16 illustrate a device 10 with an optional malabsorptionsleeve 50. Nutrients exiting the outlet 24 of the passageway 20 moveinto the sleeve 50 before exiting the sleeve 50 at the distal end 52 ofthe sleeve. When the device is deployed within the gastrointestinalsystem of a patient such as is depicted in FIG. 1, the sleeve 50 maypreferably be located within the duodenum. The sleeve 50 may have alength selected to line a predetermined length of the small bowel.Preferably, the sleeve will extend beyond the common papilla CP.

The sleeve 50 is preferably constructed such that the nutrients passingtherethrough do not pass through the wall of the sleeve 50.Alternatively, the sleeve 50 may be permeable (indicated by perforations54) for nutrients to pass through the wall of the sleeve 50 at a reducedrate. Control over nutrient permeability may be obtained by selection ofthe materials used for the sleeve 50, e.g., by selecting materials thatare themselves permeable to the nutrients. It may also be preferred thatthe sleeve 50 exhibit some permeability to duodenal fluids that may,e.g., improve the motility of ingested food, reduce the likelihood ofobstruction in the sleeve 50, etc.

Alternatively, the sleeve 50 could be constructed of materials that areimpermeable to nutrients with permeability of the sleeve 50 beingprovided by structural features in the sleeve 50 such as fenestrations54 formed in the sleeve 50.

The size, shape, spacing, etc. of the fenestrations 54 (as well as thelength of the sleeve 50) can all be selected to control the absorptionof nutrients within the portion of the proximal bowel occupied by thesleeve 50.

x. Drug Delivery

The residence of any of the foregoing devices (e.g., device 10) in thegastrointestinal tract provides an opportunity for convenient drugdelivery. For example, the device 10 may be coated with drugs to bereleased over time. Also, any of the chambers (such as chambers 30, 40)may be filled with a drug solution. The material of the chambers 30, 40may be selected to be permeable to such drugs so that they aredischarged over time. The chambers 30, 40 can be re-filled as desiredwith a fresh supply of a drug solution.

FIG. 21A illustrates an embodiment to avoid excessive shrinkage of achamber 30, 40 as a drug passes through a permeable chamber membrane. InFIG. 21A, a proximal chamber 30 ₁ is illustrated. It will be appreciatedthis feature may also be applied to a distal chamber (e.g., chamber 40).

In FIG. 21, the chamber 30 ₁ is formed of a double walled construction.The inner wall 30 a ₁ is a non-permeable wall to retain fluid in theinterior 33 ₁ and maintain the inflation of the chamber 30 ₁ to a sizesufficient to resist passage through the pylorus. The inflating fluidmay be any of those previously described.

An outer wall 30 b ₁ surrounds the inner wall 30 a ₁ with opposingsurfaces defining an outer volume 33 a ₁. The outer volume 33 a ₁ may befilled with a drug-containing solution using separate fill ports such asthose described with reference to port 12.

The outer wall 30 b ₁ is selected of a material which is permeable tothe drug. Accordingly, the drug is dispersed over time for the desiredtherapeutic effect. The outer volume 33 a ₁ may be re-filled with thedrug solution as needed.

The potential drugs for use with the device are many and varied. Forexample, such drugs could include satiety-inducing drugs such as PYY orghrelin. Such drugs may also include enzyme inhibitors (e.g., drugs toinhibit amylase, trypsin or lipase).

C. Colonic Bypass

a. General Description

FIGS. 24-27 illustrate the use of the device 10 of the fore-goingdescription in combination with a secondary device 510 for creating anartificial fistula from the stomach S to the colon C. While thesecondary device 110 can be used separately as an independent therapy,it is most preferably used in combination with a pyloric restrictiondevice such as (but not limited to) any of the fore-going devices (e.g.,device 10).

The methods, kits and systems of the present invention preferablyprovide for control over the flow of nutrients ingested by a subjectthrough the normal or primary path that includes thestomach-duodenum-jejunum-ileum-colon. That control is obtained bypreferably restricting or preventing the flow of nutrients through theprimary path while providing a secondary path for nutrients. Thesecondary path moves nutrients from the stomach directly to the smallintestine and/or colon such that absorption of the nutrients is reduced.

Restriction of the flow of nutrients through the primary path may becontrolled by any suitable technique or techniques. Although a devicesuch as device 10 is most preferred, other techniques that may be usedto restrict nutrient flow through the primary path include, but are notlimited to, banding, surgical techniques, etc. at different points inthe gastrointestinal system (e.g., in the stomach, at the pyloricsphincter, in the small intestine, etc.). Also, the methods and devicesof the present invention may restrict nutrient flow through the pyloricsphincter—surgically and/or by other techniques. Techniques forrestricting flow through the pyloric sphincter include those describedearlier in this application with reference to describing the prior art.

b. Primary Path Flow Control

FIG. 24 depicts two gastric flow control devices according to thepresent invention deployed within the gastrointestinal system of apatient. In the gastrointestinal deployment depicted in FIG. 1, aprimary gastric flow control device 10 is such as that described above.In the embodiment shown, the device 10 includes a valve (such as thatdescribed with reference to FIG. 19).

c. Secondary Path Flow Control

FIG. 24 also depicts one example of a secondary gastric flow controldevice 510 deployed within the gastrointestinal system of a patient. Thesecondary gastric flow control device 510 is deployed within the stomachof the patient such that a proximal portion of the device 510 is locatedwithin the stomach S and the distal portion of the device 510 is locatedwithin the colon C. The distal portion could have an optional extendedsleeve in the colon C (such as sleeve 50 described with reference toFIG. 16).

The device 510 may be of similar construction to device 10 withmodifications as will be described. The device 510 includes a passageway520, first (or proximal) expandable chamber 530, and a second (ordistal) expandable chamber 540.

As compared to the primary gastric flow control device 10, the secondarygastric flow control device 510 may preferably include expandablechambers 530, 540 that, upon expansion, form an elongated disc shape asopposed to a rounded ball shape of chambers 30, 40. The lower profileshape of the expandable chambers 520, 530 help prevent or reduce thelikelihood of occlusion in the colon C and to allow gastric contentseasy access to the passageway 520.

The diameter of the second expandable chamber 540 could be any size thatwould prevent the chamber 540 from passing through the entry incision.The depth of the chamber 540 may preferably be no more than 1-2 cm toprevent occlusion (i.e. extend no more than 1-2 cm into the colon).

The surface of the chamber 530 located on the gastric end of the device510 may preferably be concave or funneled. Such a shape facilitates theflow of stomach contents to the colon.

In the depicted deployment, the passageway 520 bridges or passes throughan anastomosis created between the stomach S and the colon C. Theproximal expandable chamber 530 is preferably located within thestomach. It may be preferred that the proximal expandable chamber 530 bepositioned in the stomach proximate the location where the greater curveof the stomach approximates the transverse colon. The distal expandablechamber 540 is located within the colon. Similar to device 10, thedevice 510 also includes an expansion port 512 that may be used toexpand the chambers 530, 540.

The secondary device 510 bridges an anastomosis created between thestomach and the colon. The secondary gastric control device 510 thusprovides a secondary path through which nutrients can pass from thestomach to the colon, bypassing the small intestine.

It may be preferred that the secondary device 510 have a largerpassageway 520 than the passageway 20 of the primary device 10. Onepotential result of providing secondary device 510 with a largerpassageway than the primary device 10 is that, if the passageway 520 isopen, a majority of ingested substances may be passed directly to thecolon through secondary device 510.

The secondary gastric flow control device 510 may include a valve orvalves as described above in connection with the primary gastric flowcontrol device 10. In some instances, both the primary device 10 and thesecondary device 510 may include valves. Typically, however, at leastthe secondary gastric flow control device will include a flowrestriction valve that can be selectively open or restrict the size ofthe passageway as therapy would warrant. It may be preferred that thesecondary gastric flow control device 510 include at least a one-waycheck valve to limit or prohibit the movement of colonic components intothe stomach.

As an alternative (or in addition to) valves that can regulate flow, thesecondary gastric flow control device 510 could be equipped with acover, cap, lid, etc. to prevent or reduce the likelihood of contentspassing into the colon from the stomach. These structures wouldpreferably be located on the gastric side to allow the practitioner to(preferably endoscopically, remotely or by some other non-surgicaltechnique) close the secondary gastric flow control device when thedesired amount of weight has been lost. By maintaining the placement ofthe secondary device 510 (but not allowing any contents to flowtherethrough) the incision would preferably be prevented from sealingover completely, thus avoiding the need to redeploy a secondary gastricflow control device in the event that the patient regains the lostweight. Alternatively, the device 510 could be plugged as described withreference to FIG. 15.

Either or both of the gastric flow control devices 10 and 510 may alsobe provided with filters on the gastric side of their respectivepassageways to prevent or reduce the likelihood of occlusion of thepassage way by food particles. The filters may be provided in the formof, e.g., domed or tented screens on the gastric side of the channel toprevent occlusion by food particles or with raised rings as describedwith reference to FIG. 22.

Another optional feature that may be included in the secondary gastricflow control device is that the passageway 520 could be embedded with,or elute, an antibiotic agent to prevent or reduce the likelihood thatcolonic bacteria can migrate from the colon to the stomach.

d. Delivery of Artificial Fistula

FIGS. 25-27 depict one method of deploying the secondary gastric flowcontrol device 510. It may be preferred that the device 510 be deployedendoscopically using a combination of a gastroscope and colonoscope 170.The colonoscope 170 may preferably be equipped with a transilluminationdevice 172 and inserted to the transverse colon. The gastroscope maypreferably deliver a camera 160 to the stomach that would allow theoperator to detect the light from the colonoscope 170 in the transversecolon.

In one alternative, two magnets (not shown, one attached to thegastroscope and one attached to the colonoscope) could be used to alignthe two scopes at the proper anatomic location and provide a definedpoint for placement. Another alternative method for placement of thegastric flow control device may involve the deployment of a balloon tothe colon through the use of a colonoscope. The deployed balloon couldbe filled with, e.g., a contrast agent, air, etc. The balloon could beinflated to a diameter of, e.g., at least one but not more than fivecentimeters (to prevent perforation of the colon). Using ultrasonicenergy, the practitioner could visualize the balloon in the colon andthereby determine the correct point of insertion of the secondarygastric flow control device.

Regardless of the placement method used, after a selected location forplacement of the secondary gastric flow control device 510 has beenidentified, a junction or opening between the stomach S and the colon Cat the selected location may preferably be formed using any suitabletechnique or techniques. In FIG. 26, an ablation tool 162 is deployed tocreate the desired junction between the stomach wall and the colonicwall at the selected location.

As depicted in FIG. 27, a needle 180 could preferably be used to piercethe walls of the stomach and colon at the selected location. A guidewire182 could then be passed through the needle 180, and a tube passed overthe guide wire. The tube may preferably contain a balloon to expand theopening between the stomach and the colon to allow for deployment of thesecondary gastric flow control device 510.

It may be preferred that the secondary gastric flow control device 510effectively creates an artificial gastrocolonic fistula. It may bepreferred that the gastric and colonic walls be firmly attached andsealed together at the point of device placement to prevent or reducethe likelihood of gastric and colonic contents leaking into theperitoneal cavity and causing peritonitis. This attachment maypreferably be maintained for at least one week (e.g., until scar tissue(fibrosis) forms to seal the incision points) and may preferably bemaintained indefinitely.

The gastric wall-colonic wall junction could be maintained by theexpandable chambers 530 and 540 in the device 510 alone. It may bepreferred, for example, that the expandable chambers 530 and 540 bepositioned such that full expansion of the chambers 530 and 540 maycause the chambers to touch or nearly touch each other such thatcomplete closure of the gastric wall-colonic wall junction may beachieved.

Alternatively, sealing of the gastric wall-colonic wall junction couldbe accomplished using one or more of, e.g., magnets, clamps, clips,staples, adhesives, etc, alone or in combination with pressure providedby the chambers 530 and 540 of device 510. The techniques (if any) usedto supplement the sealing provided by chambers 530 and 540 could bemaintained indefinitely or could be made to degrade at a defined rate(biodegradable, pH sensitive, etc.).

e. Alternative Embodiments

i. Alternative Structure

FIG. 28 schematically depicts one alternative secondary gastric flowcontrol device 610. The device 610 may preferably be deployed in thesame locations as the device 610 described above. One difference in thedevices, however, is that device 610 includes a pair of expandablechambers 632 and 634 on one end and a pair of expandable chambers 642and 644 on the opposite end of a passage 620. The chambers 634 and 644on the peritoneal side of each opening may preferably help seal theincisions and keep the passageway 620 from migrating. The passageway 620may preferably be of any selected length and may preferably have someflexibility to allow for independent movement of the stomach and colon.

ii. Fistula to Small Intestine

Although the secondary gastric flow control devices 510 and 610 aredescribed as being deployed to provide a passageway between the stomachand the colon, the secondary gastric flow control devices used inconnection with the present invention may alternatively provide a pathfrom the stomach into the small intestine. If so deployed, it may bepreferred that the secondary gastric flow control device provide apassage from the stomach into the jejunem.

Deployment of a secondary gastric flow control device into the smallintestine may include, e.g., passing a needle through a gastroscope andpiercing the wall of the stomach and the wall of the small intestinewith the needle. Contrast solution could then be inserted to the regionof small intestine and visualized by ultrasound. If the placement of theneedle is not in the desired region of the small intestine the needlecould be removed and inserted into a different area of the smallintestine. Once the needle is in the correct position a guide wire couldbe passed through the needle and a tube could be passed over the guidewire. The tube may preferably contain a retracting structure to deploywithin the small intestine, allowing the practitioner to pull the smallbowel into contact with the stomach. The retracting structure could bein the form of, e.g., a T clip, a claw, a hook, an expandable bulb/disc,etc. Once the stomach and small intestine are positioned next to eachother, a secondary gastric flow control device could be deployed in asimilar manner as described above for the colonic devices.

In addition to, or in place of, the techniques described herein forcreating passages between the stomach and colon or small intestine,other methods of creating anastomoses are known, e.g., surgicaltechniques, the laparoscopic/endoscopic techniques described in, e.g.,U.S. Pat. No. 5,330,486 (Wilk), etc.

The devices of the present invention may preferably be adapted fordelivery into the gastrointestinal system endoscopically, although otherplacement techniques and methods may also be possible. A variety ofdifferent delivery methods and structures may be described in, e.g.,U.S. Pat. Nos. 4,315,509 (Smit); 4,501,264 (Rockey); and 5,306,300(Berry); as well as U.S. Patent Publication No. US 2003/0040804 A1(Stack et al.).

D. Single or Coordinated Therapy

The pyloric narrowing of device 10 is an independent therapy for reasonsalready discussed. Similarly, device 110, forming an artificial fistulabetween the stomach and intestines, is an independent therapy. Fistulasbetween the stomach and colon (referred to as “gastrocolic fistula”) arerare but known. Such fistula are associated with significant weight losssince nutrients bypass the absorptive lengths of the small intestine.Such fistula are described in the following articles: Pitsinis, et al.,“Gastrocolic Fistula as a Complication of Percutaneous EndoscopicGastrostomy”, European Journal of Clinical Nutrition, Vol. 57, pp.876-878 (2003); Thyssen, et al., “Medical Treatment of BenignGastrocolic Fistula”, Annals of Internal Medicine, Vol. 118, No. 6, pp.433-435 (1993); Cennamo, et al., “A Rare Gastric Ulcer Complication: theGastrocolic Fistula. A Case Report.”, Chir. Ital., Vol. 53, No. 6, pp.869-872 (2001); Wagtmans, et al., “Persistent Diarrhoea inCholecystocolic and Gastrocolic Fistula after Gastric Surgery”, Neth. J.Med., pp. 218-221 (December 1993) and Tavenor, et al., “GastrocolicFistula: A Review of 15 Cases and an Update of the Literature”, J. Clin.Gastroenterol., pp. 189-191 (April 1993).

The use of device 510 permits attaining weight loss through such afistula in a manner which controls the fistula. The device could be usedto provide a rapid weight loss. As an independent therapy, the device510 can be used as a bridge to a more invasive bariatric surgery. Forexample, some patients may not be candidates for a Roux-en-Y proceduredue to surgical risks associated with their very high body mass index.The device 510 can be applied in a less invasive procedure and permit arapid weight loss to a point the patient is an acceptable candidate forthe Roux-en-Y.

In combination with the device 10, the device 510 can be used as a rabidweight loss. Then, device 510 can be plugged or removed with device 10used to maintain a lower weight.

With the device 510, a patient may preferably be instructed to drinkelectrolyte-rich solutions. Such solutions are commonly used in thetreatment of cholera. Also, it may be advisable to treat such patientswith drugs to reduce stomach acid production.

As used herein and in the appended claims, the singular forms “a,”“and,” and “the” include plural unless explicitly limited to thesingular form or the context clearly dictates otherwise.

All references and publications cited herein are expressly incorporatedherein by reference in their entirety into this disclosure. Illustrativeembodiments of this invention are discussed and reference has been madeto possible variations within the scope of this invention. These andother variations and modifications in the invention will be apparent tothose skilled in the art without departing from the scope of theinvention, and it should be understood that this invention is notlimited to the illustrative embodiments set forth herein. Accordingly,the invention is to be limited only by the claims provided below andequivalents thereof.

1. An apparatus for creating a fistula between a stomach and anintestine of a patient, said apparatus comprising a flow controller forcreating a fistula from said stomach to said intestine of said patientcomprising: a) a passageway having an internal lumen with an inlet endand an outlet end, said passageway sized to extend from said stomach tosaid intestine with said inlet residing in said stomach and with saidoutlet residing in said intestine, and having a valve for controllingthe flow of contents through the passageway; b) a first expandablechamber attached to the passageway proximate said inlet; and c) secondexpandable chamber attached to the passageway proximate said outlet;wherein said first and second chambers are adapted to seal againstopposing tissue of at least one of said stomach and said intestine uponexpansion of said chambers; and d) an anchor for securing thepassageway, wherein said passageway is completely outside the pylorus.2. An apparatus of claim 1, further comprising an anchor for securingthe passageway at the inlet end or at the outlet end.
 3. An apparatusaccording to claim 2, wherein the anchor is selected from the groupconsisting of magnets, clamps, clips, staples and adhesives.
 4. Anapparatus according to claim 2, wherein said anchor comprises: f) athird expandable chamber attached to the passageway proximate saidinlet; and g) a fourth expandable chamber attached to the passagewayproximate said outlet; wherein said first and third chambers and saidsecond and fourth chambers are adapted to form first and secondcooperating pairs upon expansion for a stomach wall to be capturedbetween said first pair of chambers, and with an intestine wall capturedbetween said second pair of chambers.
 5. An apparatus according to claim1, wherein said valve is a one way valve.
 6. An apparatus according toclaim 1, wherein said valve is a flow restriction valve.
 7. An apparatusaccording to claim 1, further comprising an injection port for inflatingfirst or second inflatable chambers.
 8. An apparatus according to claim5, wherein the first and second inflatable chambers can be inflated witha liquid or a gas.
 9. An apparatus according to claim 4, furthercomprising an injection port for inflating third or fourth inflatablechambers.
 10. An apparatus according to claim 9, wherein the third andfourth inflatable chambers can be inflated with a liquid or a gas. 11.An apparatus according to claim 1, wherein the said outlet end comprisesa sleeve.
 12. An apparatus according to claim 1, wherein the passagewayis adapted to elute an antimicrobial agent.
 13. An apparatus accordingto claim 1, wherein the inlet end comprises a cover to prevent flow ofcontents from the stomach into the intestine.
 14. A method ofpositioning an apparatus according to claim 1 comprising: a)administering a gastroscope to a patient; b) administering a colonscopeto the patient, wherein the colonscope has a detectable component; c)detecting the detectable component of the colonscope to identify a pointof placement; d) forming an opening at the point of placement; e)delivering the apparatus of claim 1 to the point of placement; f) andexpanding the first and second chambers.
 15. The method of claim 14,wherein the detectable component of the colonscope is a light.
 16. Themethod of claim 14, wherein the detectable component of the colonscopeis a detectable balloon.
 17. The method of claim 16, wherein the ballooncontains a contrast agent.
 18. The method of claim 14, wherein thedetectable component of the colonscope is a magnet and the gastroscopecomprises a magnet.
 19. The method of claim 14, wherein the opening isformed at the point of placement using a needle.
 20. The method of claim19, wherein the opening is formed by enlarging the opening made by theneedle with a balloon.
 21. The method of claim 14 wherein the apparatusof claim 1 is delivered by an endoscope.
 22. The method of claim 14,wherein the chambers are expanded by delivering a fluid through aninjection port.
 23. A method of positioning an apparatus according toclaim 1 comprising: g) administering a gastroscope to a patient; h)administering a colonscope to the patient, wherein the colonscope has adetectable component; i) detecting the detectable component of thecolonscope to identify a point of placement; j) forming an opening atthe point of placement; k) delivering the apparatus of claim 4 to thepoint of placement; l) and expanding the first, second, third, andfourth chambers.